A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System

NCT07227532 | Recruiting FDA Device

• 1 other identifier: BWI202405
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure

  PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.

  Within 7 days post index procedure

• Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes

  Freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmias (atrial fibrillation \[AF\], atrial tachycardia \[AT\] or atrial flutter \[AFL\] of unknown origin) episodes will be reported. AFL of unknown origin is defined as all AFL except those Cavotricuspid isthmus CTI dependent AFL as confirmed by 12-Lead electrocardiogram (ECG) and entrainment maneuvers in an evaluation period study.

  Day 61-1095 post-index procedure

Study Arms (1)

Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

EXPERIMENTAL

Participants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator.

Device: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

Interventions

Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator DEVICE

Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.

Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
• Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)
• Willing and capable of providing consent
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements

You may not qualify if:

• Previously diagnosed with persistent or long-standing persistent AF (more than \[\>\] 7 days in duration)
• Previous surgical or catheter ablation for AF
• Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
• Current enrollment in an investigational study evaluating another device or drug
• Life expectancy less than 12 months
• Any contraindications as defined in the Protocol

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (7)

OC Memorial

Fountain Valley, California, 92708, United States

RECRUITING

Community Memorial Hospital

Ventura, California, 93003, United States

RECRUITING

Orlando Health Heart and Vascular Institute

Orlando, Florida, 32806, United States

RECRUITING

The Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

RECRUITING

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

RECRUITING

Winchester Medical Center

Winchester, Virginia, 22601, United States

RECRUITING

Mercy Hospital

Janesville, Wisconsin, 53548, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Biosense Webster, Inc. Clinical Trial

  Biosense Webster, Inc.

  STUDY DIRECTOR

Central Study Contacts

Emily Purcell

CONTACT

+1 949 230 3701; EPurcel1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2025
• First Posted: November 12, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (7)